LB Pharmaceuticals (LBRX) investor relations material

Strategic focus and pipeline

• Advancing late-stage clinical trials for schizophrenia, bipolar depression, and adjunctive major depressive disorder, with a streamlined path to approval in schizophrenia following positive FDA feedback.

• LB-102, a derivative of amisulpride, is designed to address limitations of existing antipsychotics, offering improved blood-brain barrier penetration, once-daily dosing, and a favorable tolerability profile.

• Robust intellectual property protection extends through approximately 2041, supporting long-term commercial potential.

• Strong financial position with $327.8 million in cash and equivalents as of June 2026, plus a recent $150 million private placement, providing runway beyond Q2 2029.

Clinical data and efficacy

• Phase 2 trial in schizophrenia demonstrated statistically significant and rapid reduction in PANSS scores at all tested doses, with effect sizes near the top of approved antipsychotics.

• Dose-dependent improvements in cognition and negative symptoms were observed, addressing key unmet needs in neuropsychiatric disorders.

• Favorable safety profile with low rates of extrapyramidal symptoms, minimal sedation, and mild to moderate adverse events similar to placebo.

• Phase 3 trial in schizophrenia is underway, with topline data expected in 1H 2027 and an open-label extension to support safety database accrual.

Expansion opportunities and market potential

• LB-102 targets a $12 billion branded antipsychotic market, with potential for expansion into bipolar depression, adjunctive MDD, and long-acting injectable formulations.

• Bipolar disorder and MDD represent significant unmet needs, with high rates of residual symptoms and poor tolerability driving discontinuation and switching.

• Planned Phase 2 trials in bipolar depression and adjunctive MDD are designed as potentially registrational, with topline data expected in 2028 and 2029, respectively.

• Additional development opportunities include negative symptoms of schizophrenia and Alzheimer's disease psychosis/agitation, with regulatory feedback and trial initiations planned.

• Lifecycle management includes development of a long-acting injectable formulation to improve compliance and expand global market reach.